NCT00629720

Brief Summary

The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology stratified into 2 age groups (2 to 7 years and 8 to 16 years). The secondary objectives are to investigate the safety and tolerability of the 2 dose regimens and to determine the effect of the 2 dose regimens on detrusor LPP.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

7 months

First QC Date

February 26, 2008

Last Update Submit

December 11, 2009

Conditions

Urinary Bladder Neurogenic

Keywords

elevated detrusor leak point pressure

Outcome Measures

Primary Outcomes (1)

  • PK parameters

Secondary Outcomes (1)

  • Safety evaluation

Interventions

alfuzosin (SL770499)DRUG

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanofi-Aventis Administrative Office

Malvern, Pennsylvania, 19355, United States

Location

Sanofi-Aventis Administrative Office

Belgrade, Serbia

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ICD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 6, 2008

Study Start

July 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

US(1)SE(1)